Lower riskMedical device recall · FDA · Published September 11, 2018
R&D Systems Human Total 25-OH Vitamin D Kit Recall: Missing Manual and Label Error
R&D Systems recalls Human Total 25-OH Vitamin D IVD ELISA Kit (REF RDKAP1971) due to missing lot-specific manual and incorrect reconstitution volume label. Affected units sold with Manufacturing Lot # 182801.
The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.
Take action
Contact the company
📍Recalling firmR & D Systems, Inc.614 McKinley Pl NE · Minneapolis, MN 55413-2610
✎ GovInfoNow plain-language explainer
R&D Systems is recalling a Human Total 25-OH Vitamin D IVD EL:ISA Kit (REF RDKAP1971) because it was shipped without the lot-specific kit booklet and the Calibrator 0 vial label incorrectly states a 2mL reconstitution volume. This could lead to inaccurate test results if users follow the wrong instructions. Read more at govinfonow.com/recall/69879-r-d-systems-human-total-25-oh-vitamin-d-kit.
“R&D Systems Human Total 25-OH Vitamin D Kit Recall: Missing Manual and Label Error.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69879-r-d-systems-human-total-25-oh-vitamin-d-kit. Based on FDA recall #Z-0410-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0410-2019%22&limit=1).
The FDA announced on September 11, 2018, that R & D Systems, Inc. voluntarily recalled Human Total 25-OH Vitamin D IVD ELISA Kits due to missing lot-specific booklets and incorrect calibrator labels. The agency issued recall number Z-0410-2019 for the Class III device.
How to tell if you have it
Brand: R&D Systems
Product: Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Lot #: 182801
The hazard
The kits were distributed without a copy of the lot-specific kit booklet. Additionally, the Calibrator 0 vial 18D1/4 label incorrectly specified a reconstitution volume of 2mL.
Context
GovInfoNow's records show R & D Systems, Inc. has 4 other recalls on record since November 1, 2018. Other recent recalls include the Quantikine Erythropoietin Controls Recall (June 14, 2022) and the Quantikine sTfR ELISA Kit Recall (January 20, 2021). Similar recent recalls of other products include the GET TESTED Vitamin D-Test recall (November 3, 2025) and the Medline TRACH TUBE KIT Recall (July 10, 2026).
How to tell if you have this one
Check for the product name 'Human Total 25-OH Vitamin D IVD ELISA Kit' with reference number RDKAP1971 and Manufacturing Lot # 182801. The kit was sold by R&D Systems.
Brand
R&D Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Documentation
Verify if the kit includes the lot-specific booklet and the Calibrator 0 vial label correctly states the reconstitution volume.
Where it went and when
Where it was distributed
Distributed in Colorado and Iowa.
Listed by the agency
Not listed
FDA distribution: “IA and CO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Iowa.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0410-2019 (September 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0410-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.